Ustekinumab in the management of Crohn's disease: Expert opinion

Alessandro Armuzzi, Sandro Ardizzone, Livia Biancone, Fabiana Castiglione, Silvio Danese, Paolo Gionchetti, Ambrogio Orlando, Fernando Rizzello, Maria Lia Scribano, Maurizio Vecchi, Marco Daperno

Research output: Contribution to journalReview article

Abstract

This expert-opinion paper reviews available evidence for the use of ustekinumab, a human interleukin 12/23 monoclonal antibody, in the treatment of Crohn's disease and discusses its potential role in the current treatment scenario for the condition. Ustekinumab appears to be associated with rapid and sustained clinical effect, as reported from the clinical research program, with additional support for potential mucosal healing. These characteristics are paralleled by a favorable safety profile, lack of immunogenicity and the presence of systemic anti-inflammatory activity. Importantly, ustekinumab requires only one single intravenous administration, while subsequent dosing is administered subcutaneously, with potential advantages for home-based therapy. Lastly, the dosage of ustekinumab is flexible. On the basis of the evidence, ustekinumab has a role in patients with primary failure or secondary loss of response to anti-tumor necrosis factor agents, as well as in those who have adverse events on front-line biologics or are reinitiating therapy after a treatment holiday. Current evidence suggests that ustekinumab may be particularly suitable in patients who present extra-intestinal manifestations of the disease or are at risk of infections. Ustekinumab may also be considered in the first-line setting, especially in frail patients, in young subjects or in those who have concomitant immune-mediated diseases.

Original languageEnglish
Pages (from-to)653-660
Number of pages8
JournalDigestive and Liver Disease
Volume50
Issue number7
DOIs
Publication statusPublished - Jul 2018

Fingerprint

Expert Testimony
Crohn Disease
Interleukin-23
Therapeutics
Intestinal Diseases
Holidays
Immune System Diseases
Interleukin-12
Ustekinumab
Biological Products
Intravenous Administration
Anti-Inflammatory Agents
Tumor Necrosis Factor-alpha
Monoclonal Antibodies
Safety
Infection
Research

Keywords

  • Administration, Intravenous
  • Biological Products/therapeutic use
  • Clinical Trials, Phase II as Topic
  • Crohn Disease/drug therapy
  • Humans
  • Tumor Necrosis Factor-alpha/antagonists & inhibitors
  • Ustekinumab/therapeutic use

Cite this

Armuzzi, A., Ardizzone, S., Biancone, L., Castiglione, F., Danese, S., Gionchetti, P., ... Daperno, M. (2018). Ustekinumab in the management of Crohn's disease: Expert opinion. Digestive and Liver Disease, 50(7), 653-660. https://doi.org/10.1016/j.dld.2018.02.017

Ustekinumab in the management of Crohn's disease : Expert opinion. / Armuzzi, Alessandro; Ardizzone, Sandro; Biancone, Livia; Castiglione, Fabiana; Danese, Silvio; Gionchetti, Paolo; Orlando, Ambrogio; Rizzello, Fernando; Scribano, Maria Lia; Vecchi, Maurizio; Daperno, Marco.

In: Digestive and Liver Disease, Vol. 50, No. 7, 07.2018, p. 653-660.

Research output: Contribution to journalReview article

Armuzzi, A, Ardizzone, S, Biancone, L, Castiglione, F, Danese, S, Gionchetti, P, Orlando, A, Rizzello, F, Scribano, ML, Vecchi, M & Daperno, M 2018, 'Ustekinumab in the management of Crohn's disease: Expert opinion', Digestive and Liver Disease, vol. 50, no. 7, pp. 653-660. https://doi.org/10.1016/j.dld.2018.02.017
Armuzzi A, Ardizzone S, Biancone L, Castiglione F, Danese S, Gionchetti P et al. Ustekinumab in the management of Crohn's disease: Expert opinion. Digestive and Liver Disease. 2018 Jul;50(7):653-660. https://doi.org/10.1016/j.dld.2018.02.017
Armuzzi, Alessandro ; Ardizzone, Sandro ; Biancone, Livia ; Castiglione, Fabiana ; Danese, Silvio ; Gionchetti, Paolo ; Orlando, Ambrogio ; Rizzello, Fernando ; Scribano, Maria Lia ; Vecchi, Maurizio ; Daperno, Marco. / Ustekinumab in the management of Crohn's disease : Expert opinion. In: Digestive and Liver Disease. 2018 ; Vol. 50, No. 7. pp. 653-660.
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abstract = "This expert-opinion paper reviews available evidence for the use of ustekinumab, a human interleukin 12/23 monoclonal antibody, in the treatment of Crohn's disease and discusses its potential role in the current treatment scenario for the condition. Ustekinumab appears to be associated with rapid and sustained clinical effect, as reported from the clinical research program, with additional support for potential mucosal healing. These characteristics are paralleled by a favorable safety profile, lack of immunogenicity and the presence of systemic anti-inflammatory activity. Importantly, ustekinumab requires only one single intravenous administration, while subsequent dosing is administered subcutaneously, with potential advantages for home-based therapy. Lastly, the dosage of ustekinumab is flexible. On the basis of the evidence, ustekinumab has a role in patients with primary failure or secondary loss of response to anti-tumor necrosis factor agents, as well as in those who have adverse events on front-line biologics or are reinitiating therapy after a treatment holiday. Current evidence suggests that ustekinumab may be particularly suitable in patients who present extra-intestinal manifestations of the disease or are at risk of infections. Ustekinumab may also be considered in the first-line setting, especially in frail patients, in young subjects or in those who have concomitant immune-mediated diseases.",
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AU - Armuzzi, Alessandro

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AU - Biancone, Livia

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AU - Danese, Silvio

AU - Gionchetti, Paolo

AU - Orlando, Ambrogio

AU - Rizzello, Fernando

AU - Scribano, Maria Lia

AU - Vecchi, Maurizio

AU - Daperno, Marco

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N2 - This expert-opinion paper reviews available evidence for the use of ustekinumab, a human interleukin 12/23 monoclonal antibody, in the treatment of Crohn's disease and discusses its potential role in the current treatment scenario for the condition. Ustekinumab appears to be associated with rapid and sustained clinical effect, as reported from the clinical research program, with additional support for potential mucosal healing. These characteristics are paralleled by a favorable safety profile, lack of immunogenicity and the presence of systemic anti-inflammatory activity. Importantly, ustekinumab requires only one single intravenous administration, while subsequent dosing is administered subcutaneously, with potential advantages for home-based therapy. Lastly, the dosage of ustekinumab is flexible. On the basis of the evidence, ustekinumab has a role in patients with primary failure or secondary loss of response to anti-tumor necrosis factor agents, as well as in those who have adverse events on front-line biologics or are reinitiating therapy after a treatment holiday. Current evidence suggests that ustekinumab may be particularly suitable in patients who present extra-intestinal manifestations of the disease or are at risk of infections. Ustekinumab may also be considered in the first-line setting, especially in frail patients, in young subjects or in those who have concomitant immune-mediated diseases.

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